BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SILVER DENTAL ARREST

    K Number: K102973 · Decision Jul 31, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    1394

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SILVER DENTAL ARREST
    K Number
    K102973
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cooley Consulting, Inc.
    Date Received
    October 6, 2010
    Decision Date
    July 31, 2014
    Product Code
    PHR
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PHR), ordered by most recent decision date.

    SDF Pro

    FDA 510(k)
    FDA Class 2 ·Dental

    Silver Fluoride Hypersensitivity Varnish

    FDA 510(k)
    FDA Class 2 ·Dental

    FAgamin®

    FDA 510(k)
    FDA Class 2 ·Dental

    e-SDF

    FDA 510(k)
    FDA Class 2 ·Dental

    Centrix FluoroSilver Silver Diamine Fluoride 38%

    FDA 510(k)
    FDA Class 2 ·Dental

    Black Diamond

    FDA 510(k)
    FDA Class 2 ·Dental
    View all